Events

EndoVive One Step Button, EndoVive Button Decompression Tube and EndoVive Low Profile Replacement Button 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Boston Scientific 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2015-09-17
  • 사례 출판 날짜
    2015-09-17
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150917.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: boston scientific endovive one step button, endovive button decompression tube and endovive low profile replacement button medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its endovive one step button, endovive button decompression tube and endovive low profile replacement button. endovive one step button: material number m00563020 (lot 1814947); moo563080 (lot 18179867 & 18212410); m00568510 (lot 18296155) endovive button decompression tube: material number m00580471 (lot 18262588) endovive low profile replacement button: m00568330 (lot 18210123, 18231256, 18249784, 18276188 & 18310069) the manufacturer has become aware that specific lots of the affected products may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the percutaneous endoscopic gastrostomy (peg) button. a user attempting to insert the decompression tube adapter will feel increased resistance when the protrusion contacts the button, and the user may then decide to pull out the decompression tube adapter, leading to delay of decompression. if the user applies additional force to fully insert the decompression tube adapter, it could dislodge the button into the stomach. if the decompression tube adapter is successfully inserted, then the increased resistance during removal could lead to pulling the entire endovive button out of the body, which would require surgical re-insertion. there is a remote possibility that manipulating the decompression tube adapter with the protrusion could lead to a tear or perforation of the button tube, which would allow for exposure to the peritoneal cavity which could then lead to infection (peritonitis). users are advised to immediately discontinue use of and segregate recalled product. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 september 2015.

Device

EndoVive One Step Button, EndoVive Button Decompression Tube and EndoVive Low Profile Replacement...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific EndoVive One Step Button, EndoVive Button Decompression Tube and EndoVive Low Profile Replacement Button
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH